Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

• ClinicalTrials.gov Identifier: NCT00516152
• Recruitment Status: Completed
• First Posted: August 15, 2007
• Last Update Posted: January 26, 2009
• Sponsor: University of California, San Francisco
• Information provided by: University of California, San Francisco

Study Description

Brief Summary:

The primary objective of this study is to assess the safety and efficacy of performing unrelated stem cell transplants using intravenous busulfan and fludarabine as preparative therapy and tacrolimus plus methotrexate as the GVHD prophylaxis regimen. The goal is to demonstrate safety, aiming for a transplant related mortality rate (TRM) of < or equal to 40% at 100 days. A TRM of > or equal to 60% will be considered unacceptable. Another goal is to demonstrate efficacy by showing and overall survival of >40% at 1-year following transplant.

Condition or disease	Intervention/treatment	Phase
Chronic Myeloid Leukemia; Acute Myelogenous Leukemia; Myelodysplasia; Acute Lymphocytic Leukemia; Severe Aplastic Anemia; Non-Hodgkin's Lymphoma; Lymphoproliferative Disease; Multiple Myeloma; Advanced Myeloproliferative Disease	Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
• Study Start Date: November 2002
• Actual Study Completion Date: November 2007

Arms and Interventions

Intervention Details:

• Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF

  Day Preparative Regimen for GVHD Prophylaxis

  • 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
  • 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
  • 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
  • 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
  • 3 Fludarabine 30 mg/m(2)IV
  • 2 REST Tacrolimus 0.01 mg/kg CIVI

  • 1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion

    • 1 Methotrexate 5mg/m(2)IV
    • 3 Methotrexate 5mg/m(2)IV
    • 6 Methotrexate 5mg/m(2)IV
    • 7 G-CSF 5mcg/kg SQ daily
    • 11 Methotrexate 5mg/m(2)IV
    • 90 Evaluate Response

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 61 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• No fully or single-antigen mismatched sibling donor is available to donate stem cells.
• Age >15 and <61
• ECOG PS < or equal to 2
• Adequate renal function with serum creatinine <2.0 mg/dl
• Pulmonary diffusing capacity >40% of predicted
• Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
• No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
• Negative serology for the human immunodeficiency virus (HIV)
• Available HLA-matched donor (see HLA compatibility requirements below)
• Signed informed consent from the recipient

Exclusion Criteria:

• Ongoing active infection
• Pregnancy and/or nursing
• Active, uncontrolled CNS leukemia
• Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
• Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.

Contacts and Locations

Locations

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Thomas G. Martin, M.D.; University of California, San Francisco

More Information

Additional Information:

UCSF Cancer Center Home Page 

• Responsible Party: Beth Davis, University of California San Francisco
• ClinicalTrials.gov Identifier: NCT00516152 History of Changes
• Other Study ID Numbers: UC-2214
• First Posted: August 15, 2007
• Last Update Posted: January 26, 2009
• Last Verified: January 2009

Keywords provided by University of California, San Francisco:

Matched Unrelated Donor; Stem Cell Transplantation; Busulfan; fludarabine; Hematopoietic Disorder

Additional relevant MeSH terms:

Leukemia; Multiple Myeloma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Aplastic; Myeloproliferative Disorders; Lymphoproliferative Disorders; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Leukemia, Lymphoid; Leukemia, Myeloid; Bone Marrow Diseases; Anemia; Vidarabine; Methotrexate; Fludarabine phosphate; Fludarabine; Busulfan